FDA Approves GSK Rectal Cancer Drug While Veradermics Hair Loss Pill Shows Strong Phase III Results

GSK's Jemperli (dostarlimab-gxly) received FDA approval as the first and only immunotherapy cleared for adults with mismatch repair deficient and microsatellite instability-high locally advanced rectal cancer, marking a significant expansion of the checkpoint inhibitor's label beyond its existing endometrial cancer indication.

Veradermics (NYSE: MANE) reported positive top-line results from Part A of its Phase III Study 304 evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in over 500 males with mild-to-moderate pattern hair loss. The drug met both co-primary endpoints: patients on once-daily dosing gained an average of 28.6 non-vellus hairs per cm² versus 6.6 for placebo, while twice-daily dosing produced a gain of 36.4 hairs per cm². Investigator assessments rated 78.4% and 82.7% of participants in the two treatment arms as improved after six months, with hair growth noted as early as month two. The results, combined with previously reported positive findings from Study 302, position VDPHL01 as a candidate to become the first FDA-approved oral pill for male pattern hair loss in nearly three decades. Shares rose roughly 6% at Monday's market open.

Haemonetics (NYSE: HAE) won FDA approval for the PerQseal Elite vascular closure system, which uses a bioabsorbable patch to seal large-bore arteriotomies and venotomies from inside the vessel, accommodating sheaths up to 26F without sutures. The device had previously received CE Mark in Europe and expands Haemonetics' vascular closure portfolio into the large-bore structural heart and endovascular procedure segment.

Solventum separately received FDA clearance for a combined wound care therapy that merges two of its existing wound care technologies, broadening its cleared indications in advanced wound management.